Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT04852458
Eligibility Criteria:
Inclusion Criteria (for observation and hydrocortisone treatment groups):
* Screening positive for PTSD Diagnostic and Statistical Manual of Mental Disorders-5 Criteria A (felt a threat to life or injury to self or neonate)
* Postpartum hemorrhage or emergency cesarean delivery
* Owner of a smart phone or email account
Exclusion Criteria (for observation and hydrocortisone treatment groups):
* Active uncontrolled psychological disturbances identified by current psychiatric admission
* Psychiatric consult during admission, or need for hospital appointed sitter during admission
* Non-English speakers requiring a translator
* Current corticosteroid use or corticosteroid use during the study period (including betamethasone for promoting fetal lung maturity)
* Cognitive impairment identified by medical chart review or patients requiring a legal guardian for medical decision making
Exclusion Criteria: (additional criteria for participants that will receive hydrocortisone)
* Self-reported hypersensitivity to hydrocortisone
* Inability to consent patient and administer study drug within 12 hours of a traumatic event
* Weight \< 45 kilograms (kg) or \>120kg
* Subjects with systemic active infections (e.g. viral, bacterial, fungal, protozoan, or helminthic)
* Subjects with uncontrolled hypertension, renal insufficiency, or decompensated congestive heart failure
* Subjects with inflammatory bowel disease
* Subjects with active or latent peptic ulcers
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04852458
Study Brief:
Protocol Section:
NCT04852458